Job Description Summary

In this role, you will be responsible for maintaining quality oversight of Contract Manufacturing Organizations (CMOs) supporting the GE HealthCare Pharmaceutical Diagnostics (PDx) division. You will develop, monitor, and sustain strong, collaborative relationships with external CMO partners, driving transparency, accountability, and continuous improvement to ensure that sterile contrast media finished products consistently meet or exceed GE HealthCare’s quality, safety, and regulatory requirements.

Job Description

Responsibilities

• Complete supplier qualification activities for prospective Contract Manufacturing Operations.

• Manage contracted colleagues hired to support outsourcing projects

• Maintain quality oversight for a number of Contract Manufacturing Operations.

• Act as a single point of contact for all quality related activities at Contract Manufacturer.

• Manage all critical quality related issues (deviations, complaints, regulatory non-compliances etc)

• Assure Corrective and Preventive Action plans are developed and executed appropriately.

• Develop and maintain Quality Agreements between GE Healthcare and Contract Manufacturers.

• Responsible for the coordination and completion of audits, participating in and/or leading audits.

• Ensure Change Controls, initiated by supplier or by GE Healthcare are managed appropriately.

• Assist in Health Authority inspection preparations and providing support throughout as required.

• Track and trend key quality indicators / metrics to monitor supplier and QMS performance.

• Assure suppliers comply with all GE Healthcare QMS, procedures and regulatory requirements.

• Develop positive relationships with all internal partners, i.e. Sites, Sourcing, Supply Chain etc

• Provide quality support for New Product Introductions and transfers project activities.

• Interact with Suppliers, Sites and Sourcing to drive improvements to minimize costs of quality.

• All other duties as assigned by manager

Qualifications and Requirements

• Bachelors Degree in Science discipline (or non-technical degree with significant experience in manufacturing, engineering or equivalent knowledge or experience or quality assurance experience, or an Associate’s Degree with major manufacturing, engineering, or quality assurance experience) or equivalent knowledge or experience.

• Effective problem solving, root-cause analytical skills to lead and influence others to drive change (cross-functionally and globally).

• Proficiency with Microsoft Excel spreadsheet development and analysis.

• An ability to travel (up to 30%)

Desired Characteristics

• Quality Site Head and/or eligibility to act as a Qualified Person

• Ability to effectively communicate within all levels of the organization

• Demonstrated collaboration, negotiation & conflict resolution skills.

• Excellent oral communication & report-writing skills in both.

• Ability to work within a matrix organisation across different cultures

• Experience managing Contract Manufacturing operations (Active Pharmaceutical Ingredients, Finished Product), Contract Laboratories, GDP Service Providers

• Experience perform release activities for Pharmaceutical Products would also be desirable.

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Behaviors

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

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Additional Information